Chronic Pain
Conditions
Keywords
chronic pain, primary care, digital therapeutic, mobile app, pain function, pain interference, psychotherapy
Brief summary
The investigators will conduct a 2-arm randomized control feasibility study to evaluate: 1) the feasibility of using the mobile app and an optional activity tracker, 2) the feasibility of conducting a 2-arm trial, and 3) estimate the effect size for planning for a larger efficacy trial based on our primary outcomes. The intervention arm will test a mobile app that aims to help people reduce pain interference who have chronic pain, as well as mental health issues with depression and anxiety. Participants in the intervention arm will also have the option to sense health data with a tracker that integrates with the app, which will inform the feasibility of this feature.
Detailed description
This study will evaluate the existing 2Morrow Chronic Pain Self-Management Program, in the form of a mobile app, as a digital therapeutic for improving patients' pain self management and function who suffer from chronic pain. Specifically, the investigators will conduct a 2-arm randomized control feasibility study to evaluate: 1) the feasibility of using the mobile app and an optional activity tracker, 2) the feasibility of conducting a 2-arm trial, and 3) estimate the effect size for planning for a larger efficacy trial based on our primary outcomes. The intervention arm will test a mobile app that aims to help people reduce pain interference who have chronic pain, as well as mental health issues with depression and anxiety. Participants in the intervention arm will also have the option to sense health data with a tracker that integrates with the app, which will inform the feasibility of this feature.
Interventions
DEVICE2Morrow Chronic Pain Self-Management Program - digital therapeutic mobile app
2Morrow Chronic Pain Self-Management Program is delivered via a mobile app that engaged patients in evidenced based psychotherapy for chronic pain, including Acceptance and Commitment Therapy and Cognitive Behavioral Therapy based activities, to improve a patient's pain self management. The mobile app also offers the ability to track activities, screen for other problems, support for communicating with medical providers, and access a coach via texting.
OTHERTreatment as usual
Treatment as usual entails continuing with treatment for chronic pain with the patient's primary care provider and any potential specialists they choose to engage with.
Sponsors
University of Washington
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized control feasibility study with two arms: intervention arm vs. control arm
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \>=18 years old * at least one ICD pain related diagnosis noted in the electronic health record (EHR) * at least 2 visits in a primary care clinic with at least one in the last 12 months * willing to use a mobile app in English * T-score for the PROMIS brief pain inventory of \>= 55 * access to a smartphone * willing to download and use a mobile app daily
Exclusion criteria
* current cancer related diagnosis (to exclude cancer related chronic pain) * plans for surgery in next 3 months * pregnant * currently receiving hospice care
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Pain Interference Scale - Short Form 6b | will be measured at baseline, 1-month, 3-month, and 6 month intervals | This self-report questionnaire consists of is a six-item that assesses the impact of pain on various aspects of a person's life (e.g., social, cognitive, emotional, physical and recreational activities) over the last 7 days. Responses are scored using a 5-point ordinal rating scale from 1 to 5 (1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Very much). Raw score totals are converted to T-score using the scoring manual. T-score of 50 is the mean for the U.S. general population with a standard deviation of 10; the higher the T-score, the worse the pain interference. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire 9 (PHQ-9) | will be measured at baseline, 1-month, 3-month, and 6 month intervals | This self-report questionnaire consists of 9 items assessing depressive symptoms consistent with criteria for Major Depressive Disorder over the past two weeks. Each item is rated on a 4-point Likert scale (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day). Item scores are summed to produce a total score ranging from 0 to 27, with higher scores indicating greater severity of depressive symptoms (worse outcome). A typical cut-off score for probable depression is ≥ 10 points. The measure has demonstrated strong psychometric properties, including high levels of sensitivity and specificity for identifying major depressive disorder. |
| Generalized Anxiety Disorder 7 (GAD-7) | will be measured at baseline, 1-month, 3-month, and 6 month intervals | anxiety symptom measure; scores range from 0-21; higher scores are worse |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKari A Stephens, Ph.D.
University of Washington
Participant flow
Recruitment details
Eligibility: aged \>=18, pain experience current and present for \>=3 months, \>=1 ICD code for common pain related condition, \>=2 primary care visits within last 12 months at time of recruitment, PROMIS Pain Interference Short Form 6b T-score \>=55, daily smartphone access, ability to download an app, willingness to engage in a 3-month chronic pain self-management program administered via an app, speak English, and consented. Exclusions: cancer pain surgery within 3 months, pregnant, on hospice.
Pre-assignment details
Patients were invited to participate via direct email with a link to an interest survey with three options: eligibility survey vs request a call back vs opt out. Those eligible were directed to an e-consent form requiring confirmation vs request a call vs confirm that they no interest in participation. Patients who confirmed interest were asked to e-consent. A study coordinator counter-signed the e-consent form and follow up with any call requests, and if needed assist with consent by phone.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 72 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants |
| Race (NIH/OMB) More than one race | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Sex/Gender, Customized Gender | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 49 |
| other Total, other adverse events | 0 / 43 | 0 / 49 |
| serious Total, serious adverse events | 0 / 43 | 0 / 49 |
Outcome results
None listed